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A Single-Center, Open-Label, Phase II, Safety and Efficacy Study of Panzem Nanocrystal Colloidal Dispersion Administered Orally in Combination With Protracted Oral Fixed-Dose Temozolomide to Patients With Recurrent Glioblastoma Multiforme


Phase 2
18 Years
N/A
Not Enrolling
Both
Recurrent Glioblastoma Multiforme

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Trial Information

A Single-Center, Open-Label, Phase II, Safety and Efficacy Study of Panzem Nanocrystal Colloidal Dispersion Administered Orally in Combination With Protracted Oral Fixed-Dose Temozolomide to Patients With Recurrent Glioblastoma Multiforme


Inclusion Criteria:



1. A histologically confirmed diagnosis of a recurrent/progressive primary WHO grade IV
malignant glioma (glioblastoma multiforme or gliosarcoma). Patients with recurrent
disease whose diagnostic pathology confirmed WHO grade IV malignant glioma
(glioblastoma multiforme or gliosarcoma) will not need re-biopsy. Patients with prior
low-grade glioma are eligible if histologic assessment demonstrates transformation to
WHO grade IV malignant glioma. Pathology must be confirmed at Duke University
Medical Center

2. Male or female, aged greater than or equal to 18 years.

3. An interval of at least 2 weeks between prior surgical resection (if conducted) or
any major surgery or 4 weeks between prior radiotherapy or chemotherapy (except
nitrosoureas which require 6 weeks) and enrollment in this protocol unless there is
unequivocal evidence of tumor progression and the patient has recovered from
toxicities associated with those therapies. However, patients treated with
chemotherapeutic agents such as VP-16 who would normally be retreated after shorter
intervals (e.g. 21 days on, 7 days off schedule) may be treated at the usual starting
time even if less than 4 weeks from the last prior dose of chemotherapy.

4. Karnofsky performance score greater than or equal to 70%.

5. Hematocrit > 29%, absolute neutrophil count > 1,500 cells/*L, platelets > 100,000
cells/*L.

6. Serum creatinine < 1.5 X upper limit of normal (ULN), serum glutamic oxaloacetic
transaminase < 2.5 X ULN; and bilirubin < 1.5 times ULN.

7. Signed informed consent form and authorization for use and disclosure of protected
health information approved by the Institutional Review Board (IRB) prior to patient
entry.

8. If sexually active, patients must use contraceptive measures for the duration of the
treatments and for 4 weeks following end of study medication.

Exclusion Criteria:

1. Current, active systemic bleeding or excessive risk of bleeding as defined by the
following: stroke within the previous 6 months, history of central nervous system or
intraocular bleed, history of septic endocarditis or evidence of intratumor
hemorrhage on pretreatment diagnostic imaging, except for stable post operative grade
1 hemorrhage.

2. Female patients who are pregnant or breastfeeding or adults of reproductive potential
not employing an effective method of birth control. (Women of childbearing potential
must have a negative pregnancy test within 48 hours prior to administration of study
medication).

3. Concurrent severe and/or uncontrolled medical disease (i.e. uncontrolled diabetes,
congestive cardiac failure, myocardial infarction within 6 months, poorly controlled
hypertension, history of labile hypertension, history of poor compliance with
antihypertensive regimen, chronic renal disease, or active uncontrolled infection)
that could compromise participation in the study.

4. Impairment of gastrointestinal function or gastrointestinal disease that may
significantly alter the absorption of study medication (i.e. ulcerative disease,
uncontrolled nausea, vomiting, diarrhea, malabsorption syndrome, bowel obstruction,
or inability to swallow the liquid).

5. Requirement for therapy with coumadin (warfarin sodium).

6. Patient is < 1 year free of another primary malignancy except if the other primary
malignancy is not currently clinically significant or requiring active intervention,
or if other primary malignancy is a basal cell skin cancer or a cervical carcinoma in
situ. Existence of any other malignant disease is not allowed.

7. Patients unwilling to or unable to comply with the protocol.

8. Grade 2 or greater peripheral sensory neuropathy

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

6-month progression free survival and median overall survival for patients receiving at least one dose

Outcome Time Frame:

Every 2 cycles

Safety Issue:

No

Principal Investigator

Annick Desjardins, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Duke University

Authority:

United States: Food and Drug Administration

Study ID:

ME-CLN-007

NCT ID:

NCT00481455

Start Date:

April 2007

Completion Date:

October 2008

Related Keywords:

  • Recurrent Glioblastoma Multiforme
  • Glioblastoma Multiforme
  • temozolomide
  • Glioblastoma

Name

Location

The Brain Tumor Center, Duke University Medical CenterDurham, North Carolina  27710